FDA.reportPublic FDA data

Push braces

Primary DI
08715669003751
Brand
Push braces
Company
Nea International B.V.
Model
1.60.1.02
Device description
Push care Neck Brace 8cm 2
Published
2023-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQKOrthosis, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQKOrthosis, CervicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08715669003751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08715669003751087156690037518715669003751

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine collar, reusableA prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31205113888cs@push.eu

Regulatory Flags#

DUNS number
410032197
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08715669003126Push braces2.10.2.112023-03-31
08715669003133Push braces2.10.2.122023-03-31
08715669003140Push braces2.10.2.132023-03-31
08715669003157Push braces2.10.2.142023-03-31
08715669003164Push braces2.10.2.212023-03-31
08715669003171Push braces2.10.2.222023-03-31
08715669003188Push braces2.10.2.232023-03-31
08715669003195Push braces2.10.2.242023-03-31
08715669008909Push Sports4.10.1.124.10.1.122023-03-31
08715669008916Push Sports4.10.1.134.10.1.132023-03-31
08715669008923Push Sports4.10.1.214.10.1.212023-03-31
08715669008930Push Sports4.10.1.224.10.1.222023-03-31
08715669008947Push Sports4.10.1.234.10.1.232023-03-31
08715669008954Push Sports4.10.2.104.10.2.102023-03-31
08715669008961Push Sports4.10.2.204.10.2.202023-03-31
08715669003041Push braces2.10.1.112023-02-20
08715669003058Push braces2.10.1.122023-02-20
08715669003065Push braces2.10.1.132023-02-20
08715669003072Push braces2.10.1.142023-02-20
08715669003089Push braces2.10.2.212023-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071315226TrendOrthofix US LLCIQK2026-04-25
00850071315233TrendOrthofix US LLCIQK2026-04-14
00749756879699DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879705DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879712DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879729DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879736DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879750DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879767DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879774DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879804DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879811DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879828DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879835DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879989DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879996DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880008DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880084DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880091DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880107DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887601DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887618DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887625DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887632DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887649DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887656DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887687DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887694DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887700DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887717DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02